Huanova Biotech Files IPO Prospectus: Pioneering Injectable, High-Compressive Self-Healing Hydrogels for Trauma Repair and Regenerative Medicine

In 2016, the global market size for biomaterials and tissue repair and regeneration exceeded US$140 billion, while China’s market size surpassed RMB 370 billion. With the intensifying global population aging and the substantial demand for organ transplantation, the clinical demand for tissue repair and regeneration will continue to grow.

Driven by the significant clinical need for human wound healing and organ repair and regeneration, Dr. Wang Huanan founded HUANOVA in 2017, focusing on the research and development, manufacturing, promotion, and sales of implantable biomedical material-based medical devices and consumables.

As a novel biomaterial, hydrogels hold immense potential for the repair of damaged human tissues and organs. The self-healing hydrogel independently developed by HUANOVA featuresRapid self-healing, high stretchability, high elasticity, strong compressive resistance, excellent operability, injectable, printable, and moldablesuch advantages and features, making it suitable for clinical applications such as trauma hemostasis, tissue adhesion, and bone repair.

Currently, HUANOVA has developed two products using self-healing hydrogel materials: an injectable hemostatic gel and an injectable bone repair gel.Among them, the injectable hemostatic gel has already achieved large-scale production and is about to enter the clinical trial phase.

Currently, materials used clinically for tissue repair and regeneration are primarily bioinert materials such as titanium alloys. Bioinert materials exhibit high mechanical strength and good toughness, making them suitable for the repair and replacement of hard tissues like bone and teeth, with significant advantages in fixation and load-bearing applications. However, the implantation of inert materials into the human body can readily trigger alloimmune reactions. Therefore, there is an urgent need for novel biomedical materials in the fields of traumatic wound healing and organ repair.

Advances in materials science and medicine have spurred the emergence of various novel biomedical materials, among which hydrogels are a prominent example. Hydrogels are synthesized through chemical (covalent) or physical (non-covalent) cross-linking of polymers and other small molecules. They are hydrophilic, three-dimensional polymeric networks capable of swelling in water, absorbing and retaining large amounts of water, without dissolving in it.

Hydrogels closely resemble human tissues, offering excellent flexibility and biocompatibility, which makes them highly suitable for tissue repair and organ regeneration. However, clinical applications of hydrogels remain scarce, with most technologies still confined to the research stage. Dr. Wang Huanan stated, “This is because numerous challenges must be addressed before hydrogels can be applied clinically. For instance, improving hydrogel strength, ensuring the safety of material sources, achieving biodegradability and absorbability, enabling properties such as injectability, printability, and moldability, and guaranteeing product stability—all these factors limit the clinical application of hydrogel materials.”

A variety of hydrogels have been developed, including high-strength hydrogels, responsive hydrogels, biomimetic hydrogels, and self-healing hydrogels.Among them, self-healing hydrogels feature rapid self-repair capabilities, fast curing rates, and recyclable processability, offering significant application value. HUANOVA is one of the few companies in China that has overcome the technical challenges and industrialization bottlenecks associated with self-healing hydrogel materials.

Wang Huanan, founder of HUANOVA, holds a Ph.D. in Biomedical Engineering from Sichuan University and a Ph.D. from the Radboud University Medical Center in the Netherlands, and completed his postdoctoral research at Harvard Medical School and the Harvard John A. Paulson School of Engineering and Applied Sciences. He has 17 years of research experience in the field of biomaterials. As early as 2010, Wang Huanan began technical development and fundamental research on self-healing hydrogel materials. In 2015, upon returning to China, he started considering the translational application of self-healing hydrogel materials. In 2016, HUANOVA was established in Shenzhen.

HUANOVA's self-healing hydrogel materials are based onDesign and Preparation Technologies for Colloidal Network Hydrogel Materials with Supramolecular Non-Covalent CrosslinkingDeveloped with safe and non-toxic raw materials, it features high mechanical strength, requires less than one minute for preoperative preparation, is easy to fabricate, and is readily adaptable for clinical adoption. It also offers advantages such as injectability, printability, moldability, and biodegradability with absorption.

Currently, HUANOVA has established technological barriers in the field of self-healing hydrogel materials, possessing ultra-low endotoxin polymer raw material purification processes, large-scale preparation technology for colloidal particles, and design and preparation technologies for self-healing hydrogels. The company holds 8 granted invention patents, 17 published patent applications, and 4 PCT patent applications.

Self-healing hydrogel materials have a wide range of applications in the medical field. Dr. Wang Huanan stated, “Based on self-healing hydrogel technology, various products can be developed to meet the needs of different clinical scenarios. For example, injectable hemostatic gels and hemostatic powders can be developed for trauma hemostasis; tissue-filling gels can be developed for medical aesthetics; and adhesive hydrogels can be developed for wound repair.”

Currently, HUANOVA is developing two injectable hydrogel products: Colloidose, an injectable hemostatic gel, and Colloid-Osteo, an injectable bone repair gel.

Colloidose® Injectable Hemostatic Gel is processed from natural gelatin. The gel material features controllable strength and strong adhesion, and can automatically degrade into water and carbon dioxide. It is primarily used for hemostasis in clinical surgeries and is suitable for various parts of the human body.It can effectively achieve hemostasis even in cases of arterial bleeding with significant blood loss and high hemorrhagic pressure. While controlling bleeding, the product also effectively adsorbs and sustainably releases active factors from wound exudate, thereby promoting tissue repair and regeneration and enhancing therapeutic efficacy.

In large-animal hemostasis experiments, Colloidose injectable hemostatic gel demonstrated rapid, reliable, and stable hemostatic efficacy in controlling spurting bleeding from the porcine carotid artery and managing deep liver trauma.

Currently, HUANOVA has established a GMP-grade cleanroom facility spanning nearly 1,000 square meters and a global self-healing ultra-production line. Colloidose, its injectable hemostatic gel, has achieved large-scale production and is poised to enter clinical trials. Wang Huanan stated, “The company’s injectable hemostatic gel isThe First Domestically Produced Injectable Hemostatic Medical Consumable, it will fill a gap in the market after launch.”

Furthermore, injectable bone graft substitutes have become a key R&D focus for companies in Europe and the United States. The Chinese market for bone graft materials is largely dominated by imported products, a situation that HUANOVA is poised to change. The company’s Colloid-Osteo, an injectable bone repair gel, is formulated from natural gelatin and osteogenic active materials. It shares the same composition as native bone tissue and effectively promotes new bone growth. It is indicated for the repair of non-load-bearing bone defects, such as filling bone defects in non-weight-bearing or low-weight-bearing areas, augmentation and stabilization following reduction of vertebral compression fractures, reinforcement of osteoporotic vertebrae, and injectable filling after resection of vertebral tumors.

There is a lack of injectable, osteoinductive consumable products for bone regeneration in the domestic market.HUANOVA’s Colloid-Osteo injectable bone repair gel combines mechanical strength, injectability, moldability, rapid curing, and osteoinductivity, effectively addressing current clinical bottlenecks and holding significant potential for future market promotion.Currently, the company’s injectable bone gel product is under development and is poised to achieve large-scale production.

Looking ahead, HUANOVA aims to bring its injectable hemostatic gel and injectable bone repair gel to market within two to three years, thereby capturing significant market share. Additionally, the company will leverage its self-healing hydrogel technology to develop a broader portfolio of new products, including tissue adhesives, tissue-filling gels, drug-loaded gels, and tissue engineering scaffolds, striving to become a leading enterprise in the fields of human trauma repair and organ regeneration.